Kornimate/medical-research-clean huggingface dataset:
the effect of message framing on blood donation-study 2

Conditions: Rh Negative Blood Donor

Summary: rh negative blood group is a rare blood group in china, as it only accounts for 0.3-0.4 percent of the han population. therefore, low inventory is often found in blood collection and supply agencies in many regions in china. in order to assess the effects of the gain-versus-loss framing message on blood donation among rh negative donors, we designed two kinds of self-administered, standardized and structured questionnaires. in addition of the basic socio-demographic characteristics, one questionnaire includes the questions which survey the attitude of saving patients lives, and the other was to survey the attitude of preventing patients from death. the questionnaires were randomly sent to rh negative blood donors.


Eligibility criteria:
inclusion criteria: * rh negative blood donors who have donated blood between 2016 and 2018. exclusion criteria: * people who are rh negative blood type but never have donated blood.
comparison of task-oriented activity based neurodevelopmental principles and gross motor task training.

Conditions: Cerebral Palsy

Summary: this study aims to find the comparison of task oriented activity based neurodevelopmental principles and gross motor task training on balance, trunk control and functional mobility in children with cerebral palsy.

cerebral palsy (cp) being a non-progressive neurodevelopmental condition, is the leading cause of chronic disability in children, making them physically and mentally handicapped and socially unapproachable. the low tone of the torso also causes postural instability, lack of mobility, and muscle stiffness in the legs. therapeutic intervention for children with cerebral palsy should be composed of goal directed, functional, and meaningful activities by considering the clinical type, degree of disability, cognitive level and interest of the child. the trunk being the central key point of the body, proximal trunk control is a prerequisite for distal limb movement control, balance, and functional mobility. since children with cerebral palsy show damage not only in the function and an ability to accomplish tasks, but also in the quality of movement. the objective of this study will be to help clinicians regarding the effectiveness of task-oriented training and gross motor functional training for children with cerebral palsy. this will be a randomized clinical trial in which participants of age 5 - 12 years with cerebral palsy will be assigned randomly for the study. population will be taken from physical therapy department of agile rehabilitation complex, bahawalpur. after taking consent, demographics including age, gender and birth history etc. will be recorded. questionnaires will be distributed among parents and their responses will be collected. questionnaires for trunk impairment scale, postural assessment scale, pediatric balance scale and gmfm-88 will be used as tools of assessment. the collected data will be analyzed in statistical package for the social sciences (spss) 27.0.

Eligibility criteria:
inclusion criteria: * children with spastic cerebral palsy * both boys and girls * age 5 - 12 years old * able to follow verbal commands * having level i or ii of gmfcs exclusion criteria: * uncooperative * on antiepileptic and anti-spastic medications * having visual or intellectual impairments * having hearing deficit * with any cardiac anomalies affecting exercise tolerance * less than 6-month post-orthopedic surgery or post-botulinum toxin injections

Keywords: balance
biomarkers in patients undergoing atrial fibrillation ablation

Conditions: Atrial Fibrillation

Summary: the investigators aim to find biomarkers to determine the success of pulmonary vein isolation for the treatment of atrial fibrillation.

the investigators perform an observational study in patients undergoing pulmonary vein ablation to treat atrial fibrillation. additionally, electrophysiological procedures not related to pulmonary vein isolation are also followed. the aim of the study is finding biomarkers that are able to predict short-term outcome of the procedure.the primary endpoint is defined as reoccurrences of atrial fibrillation within the first three months after pulmonary vein isolation.

Eligibility criteria:
inclusion criteria: * patients with atrial fibrillation scheduled for pulmonary vein isolation with either radiofrequency of cryoballoon * patients scheduled for an electrophysiological study without ablation * patients with a catheter ablation at the cavotricuspid isthmus for the treatment of right atrial flutter exclusion criteria: * patients with concurrent pulmonary vein isolation and ablation of the cavotricuspid isthmus * acute myocardial infarction, coronary artery bypass graft surgery or open heart surgery within less than 3 months prior to inclusion
in-office clinical study of the solo+ ttd

Conditions: Ear Infection; Otitis Media

Summary: the objective of this study is to evaluate the safety and effectiveness of the solo+ tympanostomy tube device (solo+ ttd) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure.

the study will be a multi-site, prospective, treatment-only study to gather safety and effectiveness data on the use of the solo+ ttd in-office with topical anesthesia in children aged ≥6 months to \<13 years.

Eligibility criteria:
inclusion criteria: * patients aged ≥6 months to \<13 years * planned tympanostomy tube insertion * patient is able to commit to the follow-up visits and assessments exclusion criteria: * anatomy that precludes sufficient visualization of the tympanic membrane * anatomy that precludes safe access to the tympanic membrane and safe use of the solo+ ttd * narrow ear canals * congenital or craniofacial abnormalities affecting the ear * no baseline audiometry or tympanometry * familial history of insensitivity to anesthetic components * patient unable to remain still or is unsuitable for protective stabilization to undergo an in-office procedure
sentinel node detection in cervical cancer

Conditions: Sentinel Lymph Node Biopsy

Summary: evaluation of sensitivity of sentinel lymph nodes for detecting nodal metastases in cervical cancer

consecutive women with stage 1a2-2a1 cervical cancer scheduled for surgery will be approached for eligibility by defined criteria. sentinel nodes will be detected by a combined use of indocyanine green and tc99 radiocolloid ( first 75 patients) and for the continuation with either the combined use or the best performing of those tracers. technical success rates, adverse events (related study intervention and overall) sensitivity and negative predictive values will be estimated. an interim analyse will be performed after 34 node positive patients based on the fleming two stage analyse. the null hypothesis of sensitivity of 85% will be tested against an estimated sensitivity of 95%. at this stage the study may be closed for futility, closed as hull hypothesis is rejected or continued to reach another 28 node positive patients. as a full pelvic lymphadenectomy will be performed after detection of sentinel nodes patient will act ast their own controls.

Eligibility criteria:
inclusion criteria: * women of age 18 years and older at the time of informed consent. * women with a pathologically proven cervical carcinoma of any histologic subtype, clinically stage 1a2- 2a1 planned for primary surgery * absence of any exclusion criteria exclusion criteria: * non consenting patients * ongoing pregnancy * inability to understand written and/or oral study information * who performance status iii or more * previous lower limb lymphedema * surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons discretion. * anesthesiologic contraindication to a laparoscopic approach at the anesthetist's discretion * locally advanced disease or intraabdominal/distant metastases at preoperative ct, mri or ultrasonography * radiologically suspect pelvic nodal metastatic disease according to the recist criteria (\>= 1 node with \>=16 mm short axis diameter) * allergy to iodine * patients with a known liver disease * patients with a significant bleeding disorder or mandatory antithrombotic treatment.
study on adherence to a mediterranean diet in a population of patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: in randomized clinical studies, the mediterranean diet has demonstrated beneficial effects on glucose and lipids levels, on body composition, on waist to hip ratio, especially in patients with type 2 diabetes. consequently, the meditteranean diet is now recommended by experts in cardiology, nutrition and diabetology. however, many of these publications have been generated in populations living around the mediterranean basin. thus, it is not sure that this diet can be used by people living outside this geographic area. we aimed to study the capacity of consecutive patients admitted in diabetology to follow the mediterranean diet recommandations during 12 months. the adherence will be studied in the real life in order to identify all limitations to follow this diet. therefore, this study may help to find solutions to reinforce adherence to this diet.

patients older than 18 years of age and consequently admitted in the dpt of diabetology in the pitié-salpêtrière and the georges pompidou euopean hospitals will be enroled in this study. after a survey of eating habits, the 14 items of the mediterranean diet (accordingly to schröder h et al., j nutr 2011) will be explained. adherence to the diet is defined by the achievement of more than 9 items from the original list of 14 items. adhesion to the diet will be studied à 3 and 12 months by questionnaires and the analysis of olive oil consumption (urine levels of hydroxytyrosol and alpha linoleic acid levels in bloood). consequences of adhesion to the diet on body weight, body composition, glucose and lipids levels, hba1c and liver enzymes in blood will be collected at 3 and 12 months. at the end of the study, patients will complete a semi-quantitative questionnaire with a sociologist in order to identify main limitations to achieve items of the diet.

Eligibility criteria:
inclusion criteria: * patient over 18 years old. * patient with type 2 diabetes regardless of the hypoglycaemic treatments used and their hba1c level. * patient referred to the diabetology day hospital of the chu pitié-salpêtrière and nutrition of the hegp for assessment of diabetes and/or for obesity assessment and dietary education as part of routine care. * patient accepting the constraints of the protocol after explanation of it and not opposing to participate in it. * patient benefiting from or entitled to health insurance coverage outside of the ame. exclusion criteria: * patient with current or recent infections (\<10 days). * patient with unstable neoplastic (with the exception of carcinoma in situ of the cervix or cutaneous epithelioma), hematological, psychiatric (with the exception of eating disorders (ed)). * pregnant or breastfeeding patient. * person under legal protection.

Keywords: type 2 diabetes mediterranean diet
video-respiratory polygraphy in children

Conditions: Sleep Apnea, Obstructive

Summary: the diagnosis of obstructive sleep apnea-hypopnea syndrome in children (osas) requires a polysomnography (psg) in a sleep lab with video surveillance and monitoring by a nurse. but psg is a cumbersome exam, sometimes difficult to perform in children. simplified exams as respiratory polygraphy (rp) which uses only respiratory signals can be used for the diagnosis of osas but studies show that it underestimates the obstructive apnea-hypopnea index (oahi) because the total sleep time cannot be accurately estimated. the use of a video camera with software synchronous with the rp software could compensate for this disadvantage, by estimating when the child is sleeping or not.

the diagnosis of obstructive sleep apnea-hypopnea syndrome in children (osas) requires the performance of a polysomnography (psg) in a sleep lab with video surveillance and monitoring by a nurse to put the sensors back on the child if necessary. psg gives the obstructive apnea-hypopnea index (oahi) necessary for the diagnosis of osa and to determine its severity. but psg is a cumbersome exam, sometimes difficult to carry out in children, with several sensors and electrodes to install (electroencephalogram (eeg), myogram (emg), occulogram (eog), necessary to determine awakening and sleep periods and intra-sleep micro-arousals, nasal cannula, thoraco-abdominal straps, pulse oximetry, actimetry to score respiratory events). psg is time-consuming for installation and analysis. simplified methods of recording and analysis are preferable in children but require validation in this population. respiratory polygraphy (rp) which uses only respiratory signals (without eeg, emg and eog) can be used for the diagnosis of osa but studies showed that it underestimated the oahi because the total sleep time cannot be accurately estimated. the use of a video camera with software synchronous with the rp software could compensate for this disadvantage, by estimating when the child is sleeping or not. the hypothesis of this study is that video-rp can identify osas in children.

Eligibility criteria:
inclusion criteria: * children with suspicion of osas * interpretable polysomnography exclusion criteria: * non-interpretable polysomnography

Keywords: child polysomnography polygraphy
pain management in osteoarthritis using the centrally acting analgesics duloxetine and pregabalin

Conditions: Hand Osteoarthritis

Summary: osteoarthritis is the most common form of arthritis worldwide. specifically, osteoarthritis of the hands affects millions of people and is a major cause of hand disability and pain. despite this, there are currently no treatments that delay or halt the development of osteoarthritis. pain is one of the major symptoms of osteoarthritis and pain management is an important factor to consider in the treatment of this condition. treatments for pain in osteoarthritis consists of local injections, anti-inflammatory gels or painkillers such as paracetamol. however, most people with osteoarthritis still have pain despite these treatments.

recent scientific studies have suggested that people with hand osteoarthritis not only feel pain in their hand joints, they also appear to have increased signals in their brain pain processing pathways. at st george's, university of london, the investigators have been conducting studies to find out which brain regions are activated in subjects with hand osteoarthritis. the investigators have found that certain brain regions (thalamus, insula, cingulate and somatosensory cortex) are activated during painful tasks in patients with hand osteoarthritis but not in healthy people. in this study the investigators will establish whether drugs that inhibit pain processing pathways in the brain can help. patients who are still having pain despite their usual painkillers will be randomly divided into 3 groups: one group will receive a placebo, the other 2 groups will receive one of two different drugs, duloxetine or pregabalin. participants will be assessed using questionnaires and a brain scan (functional mri) before and after 13 weeks of taking the tablets. this study will help us to understand the ways in which people feel pain in osteoarthritis. if our trial proves successful,drugs that dampen central pain pathways could be used in combination with local pain-relieving drugs to improve treatment and reduce disability in patients with hand osteoarthritis.

Eligibility criteria:
inclusion criteria: * participants fulfilling the american college of rheumatology (acr) criteria for the diagnosis of hand osteoarthritis * participants with hand osteoarthritis presenting to rheumatology outpatient clinics and primary care. * participants will be right or left handed * male or female * age between 40 and 75 * participants will be on usual care for hand osteoarthritis including paracetamol and/or non-steroidal anti-inflammatory drugs exclusion criteria: * participants with other rheumatological diagnoses e.g. rheumatoid arthritis * current or planned pregnancy * contraindications to duloxetine or pregabalin * history of depression * recent surgery * previous use of duloxetine and/or pregabalin

Keywords: pain
a trial to evaluate the safety and tolerability of a novel medical food for management of iron deficiency anemia

Conditions: Iron Deficiency Anemia

Summary: this is a phase 1 clinical trial designed to evaluate the safety and tolerability of a novel medical food utilizing a nutritional strain of yeast for management of iron deficiency anemia.

the investigational product is a medical food and is the result of discoveries following extensive research on two preclinical models carried out by a team of researchers at penn state university. this study will utilize the standard "3+3" rule-based dose-escalation schemes, which use predetermined dose levels and cohorts of three patients. the total time commitment for each subject is approximately three months.

Eligibility criteria:
inclusion criteria: * hemoglobin, (hgb) 7-10 g/dl; transferrin saturation \<20%; and serum ferritin \<20ng/ml exclusion criteria: * pregnant or sexually-active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception (tubal ligation or otherwise be incapable of pregnancy, hormonal contraceptives, spermicide plus barrier or intrauterine device). * present consumption of iron supplements or multivitamins must be switched to vitamins not containing iron, such as the multivitamin centrum silver. no washout period is necessary since it will be apparent from the ongoing anemia that any current supplements are ineffective. * current anemia not attributed to immune deficiency, (id) (e.g. other microcytic anemia or hemolytic, macrocytic, sideroblastic or myelosuppression or chemotherapy or radiotherapy induced anemia). * active malignancy within 1 year. basal or squamous cell skin cancer is not exclusionary. * aspartate aminotransferase, (ast) or alanine aminotransferase, (alt) at screening greater than 1.5 times the upper limit of normal. * known positive hepatitis b with evidence of active hepatitis. * known positive hiv-1/hiv-2 antibodies (anti-hiv). * patient has a current diagnosis of asthma and is actively using an anti-asthmatic therapy. * received an investigational drug within 30 days of screening. * hemochromatosis or other iron storage disorders. * unregulated hypertension * chronic kidney disease. * chronic inflammatory condition including but not limited to lupus and rheumatoid arthritis. * significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of new york heart association, (nyha) class iii or iv congestive heart failure. * smoking * irritable bowel syndrome * any other laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator puts the subject's disease management at risk or may result in the subject being unable to comply with study requirements. * breastfeeding planned on or after enrolling in the study. * known allergy to yeast * currently on monoamine oxidase inhibitors, (maoi's) or demerol
an evaluation of the efficacy and safety of csf-1 in the temporary correction of presbyopia (near-1)

Conditions: Presbyopia

Summary: this is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study evaluating the safety and efficacy of csf-1 in the temporary correction of presbyopia.


Eligibility criteria:
inclusion criteria: * subjects must have presbyopia. exclusion criteria: subjects must not: * have any contraindications to the study medications or diagnoses that would confound the study.
migs vs slt comparison in glaucoma patients

Conditions: Glaucoma

Summary: to compare the intraocular pressure (iop) and number of glaucoma medications lowering of microinvasive glaucoma surgery (migs) with the implantation of the trabecular device hydrus (ivantis) as a solo procedure and 360° selective laser trabeculoplasty (slt) to treat primary open angle glaucoma (poag).

eligible study patients diagnosed with poag and not sufficiently controlled by, intolerant of, or non-compliant with their current iop-lowering regimen. patients with iop\>21 mm hg upon at least two consecutive measurements. study subjects with typical glaucomatous visual field (vf) loss on octopus or humphrey automated perimetry (carl zeiss meditec, dublin, ca) and glaucomatous alterations to the optic nerve head. visual field classified as glaucomatous according to the european glaucoma society guidelines. exclusion criteria : eye surgery in the previous 6 months, any previous surgery for glaucoma, evidence of glaucoma of a type other than poag, and medication with systemic or topical steroids.

Eligibility criteria:
inclusion criteria: * primary open angle glaucoma diagnosis, intolerant or unresponsive to therapy or not controlled with therapy exclusion criteria: * eye surgery in the previous 6 months, any previous surgery for glaucoma, evidence of glaucoma of a type other than poag, and medication with systemic or topical steroids

Keywords: migs slt
a feasibility study of advance plasma therapy001 plasma/nitric oxide therapy for the treatment of diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: the clinical trial will assess the delivery of nitric oxide topically to the diabetic foot ulcer wound and the surrounding wound area as it related to wound healing. the objective of the study is to assess the nitric oxide therapy treatment time (the number of minutes to deliver the treatment) and frequency (number of days per week to treat) to determine the most optimal treatment time and frequency to develop a rationale for safety and efficacy for the final apt001 clinical study.

apt001 is a medical device that generates nitric oxide (no) from ambient room air within a defined plasma stream. this study is a randomized, prospective, multi-center feasibility study that will assess the effect of nitric oxide treatment time (minutes) and frequency (days/week) on wound healing in adults with diabetic foot ulcers (dfus) and to provide information that will be used to develop final safety and effectiveness hypotheses for a pivotal trial of the apt001 device.

Eligibility criteria:
inclusion criteria: * diabetes type 1 or type 2 * wound size greater than or equal to 1 cm2 and less than or equal to 16 cm2 * hba1c less than or equal to 12 % * single full thickness dfu on the plantar aspect of toes or foot * ankle brachial index greater than or equal to 0.7 exclusion criteria: * infection of the ulcer * active charcot's disease * wound involves deeper tissues including bone or tendon * negative pressure therapy on affected foot or hyperbaric oxygen therapy

Keywords: dfu